Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110 - Full Text View

Sponsor:	Biosynexus Incorporated
Collaborator:	GlaxoSmithKline
Information provided by:	Biosynexus Incorporated
ClinicalTrials.gov Identifier:	NCT00631878

Purpose

"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.

Condition	Intervention	Phase
Neonatal Staphylococcal Sepsis	Drug: Pagibaximab (formerly BSYX-A110)	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Immunoglobulins Pagibaximab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Biosynexus Incorporated:

Primary Outcome Measures:

Safety and tolerability. [ Time Frame: 0 - 52 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the pharmacokinetics and positive cultures. [ Time Frame: 0 - 52 days ] [ Designated as safety issue: Yes ]

Enrollment:	53
Study Start Date:	November 2001
Study Completion Date:	August 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
10 mg/kg: Experimental 10 mg/kg was given on Days 0, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
30 mg/kg: Experimental 30 mg/kg was given on Days 0, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
60 mg/kg: Experimental 60 mg/kg was given on Days 0, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
90 mg/kg: Experimental 90 mg/kg was given on Days 0, 14	Drug: Pagibaximab (formerly BSYX-A110) Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.

Detailed Description:

"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis Infection" will be the first study of BSYX-A110 in the target population of hospitalized, very low birth weight infants. The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.

This will be a randomized, double blind, placebo controlled, dose escalating study of BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30, 60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth. Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The primary objective of this study is to evaluate safety and tolerability. The secondary objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during the study period will be recorded and analyzed.

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must meet all of the following criteria at the time of first infusion (Day 0):

3-7 days of age, inclusive
Birth weight of 700-1300 grams
Survival expected for at least 1 week after infusion
Inpatient in a Neonatal Intensive Care Unit with intravenous access
Written informed consent obtained from the parent(s) or guardian

Multiple gestations:

Siblings from multiple gestations may be enrolled if they each meet the entry criteria
No more than 4 subjects in any birth weight or dose cohort may be siblings

Exclusion Criteria:

Patients may have none of the following at either the first or second dose:

Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
Life threatening hemodynamic instability
Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:

i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
Known or suspected hepatic or renal insufficiency
Persistent seizure disorder
Immunodeficiency other than due to prematurity
A history of immune globulin administration prior to first study drug infusion
Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
Any of the following laboratory findings
1. BUN or creatinine > 1.5 x upper limit of normal for age
2. AST (SGOT), ALT (SGPT) or total bilirubin > 1.5 x upper limit of normal age
3. Direct bilirubin of > 2.0 mg/dL
4. Hemoglobin < 9.0gm/dL
5. White Blood Count < 2,000 cells/mm3
Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
Expectation that the patient will not be able to be followed for the duration of the study.
Mother with serology positive for hepatitis B surface antigen
Receipt of Hepatitis B vaccine since birth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631878

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Biosynexus Incorporated

GlaxoSmithKline

Investigators

Principal Investigator:

Leonard Weisman, MD

Baylor College of Medicine

More Information

Additional Information:

Biosynexus Incorporated This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biosyneuxs Incorporated ( Gerald Fischer, MD, President and CEO )
Study ID Numbers:	MAB-N002
Study First Received:	February 29, 2008
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00631878 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biosynexus Incorporated:

Staphylococcal
Monoclonal antibodies
Very Low Birth Weight Infants
Prophylaxis

Additional relevant MeSH terms:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Immunologic Factors
Physiological Effects of Drugs
Bacteremia
Infection
Pharmacologic Actions

Inflammation
Antibodies, Monoclonal
Staphylococcal Infections
Gram-Positive Bacterial Infections
Sepsis
Pathologic Processes

ClinicalTrials.gov processed this record on November 05, 2009